Identity
- Trade Name
- Reflect Implant System FDA UDI
- Generic Name
- Dental bone matrix implant, metallic FDA UDI
- Device Name
- Reflect Recover 3.5mm X 13mmL FDA UDI
- Model / Reference
- RR3513C FDA UDI
- Description
- Reflect Recover 3.5mm X 13mmL FDA UDI
Identifiers
- Catalog Number
- RR3513C FDA UDI
- Primary DI / UDI-DI
- 00817773023040 FDA UDI
- 510(k) Number
- K180924 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental bone matrix implant, metallic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental bone matrix implant, metallic
Reflect Implant System by Integrated Dental Systems, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180924 also covers:
- 0817773021046 — Integrated Dental Systems, LLC
- Reflect — Integrated Dental Systems, LLC
- Reflect Implant System — Integrated Dental Systems, LLC
- Reflect Implant System — Integrated Dental Systems, LLC
- Reflect Implant System — Integrated Dental Systems, LLC
- Reflect Implant System — Integrated Dental Systems, LLC
- Reflect Implant System — Integrated Dental Systems, LLC
- Reflect Implant System — Integrated Dental Systems, LLC
- Reflect Implant System — Integrated Dental Systems, LLC
- Reflect Implant System — Integrated Dental Systems, LLC
- Reflect Implant System — Integrated Dental Systems, LLC
- Reflect Implant System — Integrated Dental Systems, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integrated Dental Systems, LLC
Sources (1)
- FDA UDI 772a6e14-ef0b-41e7-9db5-7406a7397196 36 fields · synced Jun 6, 2026